US2023032033A1PendingUtilityA1

Adaptation of medicament delivery in response to user stress load

Assignee: INSULET CORPPriority: Jul 29, 2021Filed: Jul 15, 2022Published: Feb 2, 2023
Est. expiryJul 29, 2041(~15 yrs left)· nominal 20-yr term from priority
A61M 2230/65A61M 2230/50A61M 2230/06A61M 2005/1726A61M 5/14248A61M 5/16836A61M 2230/63A61M 5/1723
40
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Claims

Abstract

Disclosed are an automatic medication delivery system includes a stress detection and response algorithm or application that may operate in cooperation with a medication delivery algorithm or application. Execution of the instructions of the stress detection and response application causes a processor to obtain a respective measurement value related to a physiological condition of a user from one or more sensors. The obtained respective measurement values are evaluated against a respective threshold measurement value. The processor determines, based on the evaluation of the obtained respective measurement values, a degree of stress the user is experiencing. In response to the determination of the degree of stress the user is experiencing, the processor may modify an imminent dosage of a liquid drug to be delivered, a time of delivery of the imminent dosage, or both. A dosage of the liquid drug may be expelled based on the modifying.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A wearable drug delivery system, comprising:
 one or more sensors operable to measure a physiological condition of a user;   a processor communicatively coupled to the one or more sensors;   a pump mechanism coupled to the processor and to a drug container, wherein the drug container is operable to store a liquid drug;   a memory coupled to the processor, the memory including programming code;   the processor, when executing the programming code, operable to:
 receive measurement values from the one or more sensors; 
 evaluate each of the received measurement values against a respective threshold measurement value corresponding to the one or more sensors; 
 determine based on a result of the evaluation of each of the received measurement values whether the user is experiencing stress; 
 in response to the determination the user is experiencing stress, estimate a degree of stress; 
 based on the degree of stress, modify a pending dosage of a liquid drug to be delivered, a time of delivery of the pending dosage, or both; and 
 expel the liquid drug according to the modified pending dosage, the modified time of delivery of the pending dosage, or both. 
   
     
     
         2 . The wearable drug delivery system of  claim 1 , wherein the one or more sensors includes a skin temperature sensor, a heart rate sensor, a skin conductance sensor, or an accelerometer. 
     
     
         3 . The wearable drug delivery system of  claim 2 , wherein the processor, prior to evaluating each of the received measurement values against the respective threshold measurement value corresponding to the one or more sensors, is further configured to:
 identify a physical activity state based on detection of an elevated heart rate of the user, a change in skin conductance of the user, or a change in body temperature of the user.   
     
     
         4 . The wearable drug delivery system of  claim 3 , wherein the processor is further operable to:
 in response to the physical activity state indicating participation in physical activity by the user, exclude a period of time corresponding to the physical activity state from the determination of whether the user is experiencing stress.   
     
     
         5 . The wearable drug delivery system of  claim 2 , wherein prior to evaluating each of the received measurement values against a respective threshold measurement value corresponding to the one or more sensors, the processor is operable to:
 determine a physical activity state of the user based on an input from the accelerometer, wherein an attribute of an accelerometer signal received as the input is used as a marker of physical activity of the user.   
     
     
         6 . The wearable drug delivery system of  claim 5 , wherein the processor is further operable to:
 in response to the physical activity state indicating participation in physical activity by the user, exclude a period of time corresponding to the physical activity state from evaluation for stress.   
     
     
         7 . The wearable drug delivery system of  claim 2 , wherein evaluating each of the received measurement values against the respective threshold measurement value corresponding to the one or more sensors, the processor is further operable to:
 determine if a skin temperature measurement received from the skin temperature sensor is lower than an earlier skin temperature measurement; and   in response to the skin temperature measurement being lower than the earlier skin temperature measurement, generate a signal indicating that the skin temperature measurement is lower than the earlier skin temperature measurement and a number of degrees lower.   
     
     
         8 . The wearable drug delivery system of  claim 2 , wherein the processor is further operable to:
 receive the measurement values from the skin temperature sensor by sampling the skin temperature measurement output by the skin temperature sensor at a high frequency to obtain a plurality of skin temperature measurements;   determine a minimum skin temperature measurement from among the plurality of skin temperature measurements;   determine a maximum skin temperature measurement from among the plurality of skin temperature measurements;   determine a standard deviation of the plurality of skin temperature measurements; and   use the determined minimum skin temperature, the determined maximum skin temperature, and the determined standard deviation when estimating the degree of stress.   
     
     
         9 . The wearable drug delivery system of  claim 1 , wherein the processor is further operable to:
 in response to receiving the inputs from a respective sensor of the one or more sensors, select a group level model from a plurality of group level models, wherein each respective group level model of the group level models enables modeling an individual stress load of a person; and   in response to applying the inputs to the selected group level model, generate an individualized stress load model for the user.   
     
     
         10 . The wearable drug delivery system of  claim 9 , wherein the processor, when determining whether the user is experiencing stress, is further operable to:
 apply inputs to the individualized stress load model;   process an output for the individualized stress load model to determine whether the user is experiencing stress; and   in response to a determination that the user experiencing stress, process the output to provide the estimated degree of stress.   
     
     
         11 . The wearable drug delivery system of  claim 10 , wherein the processor when modifying the pending dosage is operable to:
 modify an amount of a liquid drug to be delivered as a basal dosage via basal delivery, modify a time for delivery of the basal dosage, modify an amount of a liquid drug to be delivered as a bolus dosage via a bolus delivery, modify a frequency of delivery of a basal dosage, or modify a time of delivery the bolus dosage.   
     
     
         12 . The wearable drug delivery system of  claim 9 , wherein the processor is further operable to:
 use based on an output from the individualized stress load model in the estimating of the degree of stress the user is experiencing; and   in response to a determination of the degree of stress the user is experiencing, modifying a drug delivery treatment plan.   
     
     
         13 . The wearable drug delivery system of  claim 1 , wherein the processor, when receiving measurement values from the one or more sensors is operable to:
 receive a measure heart rate variability;   compare the measured heart rate variability to a heart rate variability threshold; and   in response to the measured heart rate variability exceeding the heart rate variability threshold, generate an indication that the user is experiencing stress.   
     
     
         14 . A method comprising:
 obtaining a respective measurement value from one or more sensors, wherein each sensor of the one or more sensors obtains data related to a physiological condition of a user;   evaluating each obtained respective measurement value against a respective threshold measurement value corresponding to the one or more sensors;   determining, based on a result of the evaluation of each of the obtained respective measurement values, a degree of stress the user is experiencing;   in response to a determination of the degree of stress the user is experiencing, modifying an imminent dosage of a liquid drug to be delivered, a time of delivery of the imminent dosage, or both; and   expelling the liquid drug according to the modified imminent dosage, the modified time of delivery of the imminent dosage, or both.   
     
     
         15 . The method of  claim 14 , wherein modifying the imminent dosage of the liquid drug to be delivered, the time of delivery of the imminent dosage, or both, further comprises:
 evaluating the degree of stress with reference to results of a machine learning algorithm trained using user responses to multiple degrees of stress; and   determining, based on a result of the evaluating, at least one of:
 a stress-modified dosage that is an amount of the liquid drug that is different from an amount of the imminent dosage of the liquid drug to be delivered, or 
 a first stress-modified delivery time that is different from an imminent delivery time of a next dosage of the liquid drug, or 
 a combination of the stress-modified dosage and the first stress-modified delivery time, or 
 a combination of the stress-modified dosage and a second stress-modified delivery time, wherein the second stress-modified delivery time is based on the stress-modified dosage and is different from the first stress-modified delivery time. 
   
     
     
         16 . The method of  claim 14 , wherein modifying an imminent dosage of the liquid drug to be delivered, a time of delivery of the imminent dosage, or both, further comprises:
 modifying an amount of a liquid drug to be delivered as a basal dosage via basal delivery,   modifying a time for delivery of the basal dosage,   modifying a frequency of delivery of a basal dosage,   modifying a time of delivery of a bolus dosage that was the imminent dosage of the liquid drug,   modifying an amount of a liquid drug to be delivered as a modified bolus dosage via a bolus delivery, or   modifying a time of delivery of the modified bolus dosage.   
     
     
         17 . The method of  claim 16 , wherein evaluating each obtained respective measurement value against the respective threshold measurement value corresponding to the one or more sensors further comprises:
 comparing a measured heart rate variability signal obtained from a heart rate sensor to a heart rate variability threshold; and   in response to the measured heart rate variability exceeding the heart rate variability threshold, generate an indication that the user is experiencing stress.   
     
     
         18 . The method of  claim 14 , wherein obtaining a respective measurement value from the one or more sensors, wherein each sensor of the one or more sensors obtains data related to a physiological condition of the user, further comprises:
 obtaining a measure of heart rate variability.   
     
     
         19 . The method of  claim 18 , further comprising:
 evaluating the respective measurement of the heart rate variability by comparing the measured heart rate variability to a heart rate variability threshold; and   in response to the measured heart rate variability exceeding the heart rate variability threshold, using a result of the comparing when estimating the degree of stress, the user is experiencing.   
     
     
         20 . A non-transitory computer-readable storage medium, the computer-readable storage medium including instructions that when executed by a processor, cause the processor to:
 obtain a respective measurement value from one or more sensors, wherein each sensor of the one or more sensors obtains data related to a physiological condition of a user;   evaluate each obtained respective measurement value against a respective threshold measurement value corresponding to the one or more sensors;   determine based on a result of the evaluation of each of the obtained respective measurement values a degree of stress the user is experiencing;   in response to the determination of the degree of stress the user is experiencing, modify an imminent dosage of a liquid drug to be delivered, a time of delivery of the imminent dosage, or both; and   cause the liquid drug to be expelled according to the modified imminent dosage, the modified time of delivery of the imminent dosage, or both.

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